MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONCORDE LIFT, LORDOTIC 9X23; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	1978-09-023L
Medical Device Problem Codes	Collapse (1099); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported by surgeon, that the concorde lift cage appeared to have collapsed and subsided on follow up x-rays.2-3 months post-op.Device remains implanted.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).The concorde lift, lordotic was not returned to the customer quality unit for evaluation.A device history record review did not find any issues that could have caused or contributed to the reported event.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.Without the return of the concorde lift, lordotic we are unable to confirm the reported issue or identify the root cause.As no issues were identified in the manufacturing and release of this device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.

• Brand Name: CONCORDE LIFT, LORDOTIC 9X23
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8383507
• Report Number: 1526439-2019-51401
• Device Sequence Number: 13950840
• Product Code: MAX
• UDI-Device Identifier: 10705034531571
• UDI-Public: (01)10705034531571
• Combination Product (Y/N): N
• Initial Reporter State: PA
• PMA/510(K) Number: K171425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 1978-09-023L
• Device Catalogue Number: 197809023L
• Device Lot Number: 204548
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR